Trial Outcomes & Findings for Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma (NCT NCT05986682)
NCT ID: NCT05986682
Last Updated: 2025-02-03
Results Overview
Duration of Treatment Duration calculated from first Blenrep dose to either treatment discontinuation (for subjects who discontinued treatment prior to study end date) or last dose (for subjects who were continuing treatment as of study end date). Descriptive statistics consisting of the median (with interquartile range) was used to summarize duration across participants.
COMPLETED
30 participants
Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
2025-02-03
Participant Flow
This was a single-site, retrospective, observational study examining longitudinal care patterns for belantamab mafodotin among relapsed and/or refractory multiple myeloma (RRMM) patients seen at Duke Cancer Institute (DCI).
57 Duke patients were identified with RRMM who began treatment with Blenrep between Aug 5, 2020 and Nov 22, 2022. 25 patients were excluded (9 concurrently receiving other therapies, 8 being followed by a local oncologist or without Blenrep Risk Evaluation and Mitigation Strategies \[REMS\] documentation, 5 with \<1 mo. of follow-up, and 3 receiving Blenrep as part of an expanded access pathway). Of the 32 remaining patients, 30 patients were randomly selected for chart abstraction.
Participant milestones
| Measure |
Multiple Myeloma/Blenrep Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023.
|
|---|---|
|
Types of Prior Therapy
Proteasome Inhibitors
|
30 Participants
n=5 Participants
|
|
Types of Prior Therapy
Monoclonal Antibodies
|
29 Participants
n=5 Participants
|
|
Types of Prior Therapy
Conventional Chemotherapy
|
20 Participants
n=5 Participants
|
|
Types of Prior Therapy
Novel Agents
|
13 Participants
n=5 Participants
|
|
Types of Prior Therapy
Stem Cell Transplant
|
19 Participants
n=5 Participants
|
|
Types of Prior Therapy
Clinical Trials
|
6 Participants
n=5 Participants
|
|
Types of Prior Therapy
Other
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
|
Current Payer type
Medicare + Commercial
|
19 Participants
n=5 Participants
|
|
Current Payer type
Medicare + Military
|
3 Participants
n=5 Participants
|
|
Current Payer type
Medicare + Medicaid
|
1 Participants
n=5 Participants
|
|
Current Payer type
Commercial Alone
|
6 Participants
n=5 Participants
|
|
Current Payer type
Medicaid Alone
|
1 Participants
n=5 Participants
|
|
Diagnosis Location
At Duke
|
15 Participants
n=5 Participants
|
|
Diagnosis Location
External Location
|
15 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
>= 10% Bone Marrow Plasma Cells
|
29 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Plasmacytoma (Total)
|
9 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Bone Plasmacytoma
|
8 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Extramedullary Plasmacytoma
|
1 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
>60% Bone Marrow plasma cells
|
17 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
≥ 100 serum free light chain (FLC) ratio
|
14 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
>1 focal lesion on MRI
|
5 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Hypercalcemia
|
6 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Renal Insufficiency
|
5 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
Anemia
|
17 Participants
n=5 Participants
|
|
Multiple Myeloma (MM) Diagnostic Characteristics
≥ 1 Bone lesion (X-ray, CT, PET)
|
21 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
IgG
|
16 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
IgA
|
9 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
IgD
|
0 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
IgE
|
0 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
IgM
|
0 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
Light Chain Only
|
0 Participants
n=5 Participants
|
|
MM Subtype - Immunoglobulin (Ig)
Non-secretory
|
5 Participants
n=5 Participants
|
|
MM Subtype - Involved Serum Free Light Chain
Kappa
|
18 Participants
n=5 Participants
|
|
MM Subtype - Involved Serum Free Light Chain
Lambda
|
12 Participants
n=5 Participants
|
|
R-ISS Score
R-ISS I
|
2 Participants
n=5 Participants
|
|
R-ISS Score
R-ISS II
|
5 Participants
n=5 Participants
|
|
R-ISS Score
Unknown
|
23 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
t(4;14)
|
1 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
t(14;16)
|
2 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
del(17p)/monosomy 17
|
4 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
1q21 gain/amplification
|
12 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
t(14;20)
|
1 Participants
n=5 Participants
|
|
High Risk Abnormalities at Diagnosis
High Risk by IMWG
|
7 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
t(6;14)
|
0 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
t(11;14)
|
3 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
MYC translocation
|
3 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
TP53 mutation
|
0 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
trisomies/tetrasomies
|
12 Participants
n=5 Participants
|
|
Standard-Risk Abnormalities at Diagnosis
Complex karyotype (when done) or karyotypic del(13)
|
14 Participants
n=5 Participants
|
|
Median Number of Lines of Therapy prior to Baseline
|
4 Lines of therapy
n=5 Participants
|
|
Number of Prior Lines of Therapy - categorical
< 4 Lines of Therapy
|
10 Participants
n=5 Participants
|
|
Number of Prior Lines of Therapy - categorical
≥ 4 Lines of Therapy
|
30 Participants
n=5 Participants
|
|
Types of Prior Therapy
Immunomodulatory Agents
|
30 Participants
n=5 Participants
|
|
Type of Refractory MM
Double
|
4 Participants
n=5 Participants
|
|
Type of Refractory MM
Triple
|
12 Participants
n=5 Participants
|
|
Type of Refractory MM
Quad
|
1 Participants
n=5 Participants
|
|
Type of Refractory MM
Penta
|
13 Participants
n=5 Participants
|
|
History of Prior Malignancy
Bladder
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Brain and Spinal Cord
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Breast
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Kidney
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Prostate
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Skin Melanoma
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Uterine
|
1 Participants
n=5 Participants
|
|
History of Prior Malignancy
Smoldering MM
|
5 Participants
n=5 Participants
|
|
History of Prior Malignancy
monoclonalgammopathy of unknown significance
|
2 Participants
n=5 Participants
|
|
Baseline ECOG
1
|
11 Participants
n=5 Participants
|
|
Baseline ECOG
2
|
3 Participants
n=5 Participants
|
|
Baseline ECOG
3
|
1 Participants
n=5 Participants
|
|
Baseline ECOG
Unknown
|
15 Participants
n=5 Participants
|
|
Baseline Renal Impairment
Normal
|
2 Participants
n=5 Participants
|
|
Baseline Renal Impairment
Mild
|
16 Participants
n=5 Participants
|
|
Baseline Renal Impairment
Moderate
|
10 Participants
n=5 Participants
|
|
Baseline Renal Impairment
Severe
|
2 Participants
n=5 Participants
|
|
Baseline Renal Impairment (as measured by Serum Creatinine levels)
Serum Creatinine ≥ 2.0 mg/dL
|
3 Participants
n=5 Participants
|
|
Baseline Renal Impairment (as measured by Serum Creatinine levels)
Serum Creatinine < 2.0 mg/dL
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Population: All patients were analyzed.
Duration of Treatment Duration calculated from first Blenrep dose to either treatment discontinuation (for subjects who discontinued treatment prior to study end date) or last dose (for subjects who were continuing treatment as of study end date). Descriptive statistics consisting of the median (with interquartile range) was used to summarize duration across participants.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Treatment Characteristics: Duration of Treatment With BLENREP
|
9.3 Months
Interval 0.7 to 21.6
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of participants who discontinued treatment with BLENREP by reason.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Treatment Characteristics: Discontinuation of BLENREP Treatment
Discontinuations for any reason
|
26 Participants
|
|
Treatment Characteristics: Discontinuation of BLENREP Treatment
Discontinuation for Disease Progression
|
22 Participants
|
|
Treatment Characteristics: Discontinuation of BLENREP Treatment
Discontinuation for Corneal or other ocular toxicity
|
4 Participants
|
|
Treatment Characteristics: Discontinuation of BLENREP Treatment
Discontinuation for Physician/Patient choice
|
3 Participants
|
|
Treatment Characteristics: Discontinuation of BLENREP Treatment
Discontinuation for other reason
|
3 Participants
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Treatment characteristics: Dosing patterns - Number of cycles of treatment with BLENREP therapy - From Treatment initiation to treatment discontinuation or last dose during study period.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
Total # of cycles
|
6.5 Cycles
Interval 2.0 to 13.0
|
|
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
# of cycles at 2.5 mg/kg^2
|
2 Cycles
Interval 1.0 to 11.0
|
|
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
# of cycles at 1.9 mg/kg^2
|
3 Cycles
Interval 1.0 to 11.0
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for Corneal AE
|
27 Participants
|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for any reason
|
27 Participants
|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for Other Ocular Toxicity
|
2 Participants
|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for Hematologic Toxicity
|
3 Participants
|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for Physician/Patient Choice
|
2 Participants
|
|
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Delay for any other reason
|
10 Participants
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Total # of Participants with Dose Reductions for Any Reason
|
19 Participants
|
|
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Dose Reduction for Corneal Adverse Event
|
13 Participants
|
|
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Dose Reduction for Hematologic Toxicity
|
6 Participants
|
|
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Dose Reduction for Other Reason
|
1 Participants
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Response categorized using modified IMWG 2016 criteria. Urine testing was not routinely done; only serum M-protein levels were used when determining response. Complete Response(CR)= negative immunofixation on the serum + absence of any soft tissue plasmacytomas + \<5% plasma cells in bone marrow aspirates. Very Good Partial Response(VGPR) = serum detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein. Partial Response(PR) = ≥50% reduction of serum M-protein. If the serum is unmeasurable, a \> 50% decrease in the difference between involved and uninvolved FLC levels is required. Stable Disease (SD) = not meeting criteria for CR, VGPR, PR, or progressive disease. Progressive Disease (PD) = \>25% increase from lowest response value in serum M-protein (the absolute increase must be \>0.5 g/dL), or definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Best Overall Response
CR
|
0 Participants
|
|
Clinical Outcomes: Best Overall Response
VGPR
|
11 Participants
|
|
Clinical Outcomes: Best Overall Response
PR
|
9 Participants
|
|
Clinical Outcomes: Best Overall Response
SD
|
9 Participants
|
|
Clinical Outcomes: Best Overall Response
PD
|
1 Participants
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.The time from the start of BLENREP treatment to the date of first occurrence of response (partial response or better).
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Time To Response
|
1.4 Months
Interval 0.7 to 3.8
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.The time from the start of BLENREP treatment to the date of the best response achieved (partial response or better).
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Time To Best Response
|
1.5 Months
Interval 0.7 to 9.9
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Population: Analyzed only for the 20 patients who achieved PR or better
The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=20 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Duration of Response
|
9.8 Months
Interval 1.1 to 20.2
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Progression-Free Survival (PFS)
|
8.4 Months
Interval 6.6 to 12.7
|
PRIMARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Summary report of patient status at the end of the study period. Duration of survival was calculated, however, median survival time for OS has not yet been reached, and therefore is not reported here.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Clinical Outcomes: Overall Survival (OS)
Alive
|
19 Participants
|
|
Clinical Outcomes: Overall Survival (OS)
Deceased
|
10 Participants
|
|
Clinical Outcomes: Overall Survival (OS)
Unknown/Lost to Follow Up
|
1 Participants
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of participants with specific ocular events of interest during treatment with BLENREP
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Presence of Ocular Toxicity
Number of Participants with a Corneal Event
|
28 Participants
|
|
Ophthalmology: Presence of Ocular Toxicity
Number of Participants with a change to Best-Corrected Visual Acuity
|
27 Participants
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of Ocular Toxicity Events (Corneal Event or Best-Corrected Visual Acuity Change) per patient, summarized by median (min, max).
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Number of Ocular Toxicity Events Per Participant
Number of Corneal Events
|
10.5 Events
Interval 2.0 to 25.0
|
|
Ophthalmology: Number of Ocular Toxicity Events Per Participant
Number of changes to Best-Corrected Visual Acuity
|
7 Events
Interval 1.0 to 25.0
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Treatments for Ocular Toxicity
Received any Treatment for Ocular Toxicity
|
30 Participants
|
|
Ophthalmology: Treatments for Ocular Toxicity
Encouraged Adherence to Eye Drop Regimen
|
15 Participants
|
|
Ophthalmology: Treatments for Ocular Toxicity
Increased Eye Drops
|
10 Participants
|
|
Ophthalmology: Treatments for Ocular Toxicity
Received a new prescription - Eye drops/ointment
|
11 Participants
|
|
Ophthalmology: Treatments for Ocular Toxicity
Other
|
1 Participants
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Distress is measured on a scale of 0-10 on the National Comprehensive Cancer Network Distress Thermometer (NCCN DT). A score of 0 represents no distress, and a score of 10 represents worst possible distress. Actionable distress is defined as a NCCN DT score of 4 or higher, and is aligned with the medical practice guidelines for management of distress in cancer patients.The median (min, max) distress score across patients is reported.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=194 Scores
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
|
1.33 DT Score
Interval 0.0 to 7.56
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Sources of distress will be assessed using the NCCN DT Problem List by examining the percentage of visits where types of problems are reported. There are five categories of distress from which patients can report problems (practical, family, emotional, physical and other problems). The categories of problems are reported as a number and % of the total number of visits where problem lists are reported.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=209 Visits
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Practical Problems
|
27 Visits
|
|
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Family Problems
|
17 Visits
|
|
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Emotional Problems
|
46 Visits
|
|
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Physical Problems
|
107 Visits
|
|
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Other Problems
|
23 Visits
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Sources of distress will be assessed using the NCCN DT Problem List by examining the percentage of visits where types of problems are reported. The problem list includes 39 possible problems from which patients can choose. The problems are reported as a number and % of the total number of visits where problem lists are reported.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=209 Visits
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Fatigue
|
69 Visits
|
|
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Pain
|
63 Visits
|
|
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Tingling in Hands/Feet
|
40 Visits
|
|
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Worry
|
33 Visits
|
|
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Getting Around
|
31 Visits
|
SECONDARY outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.To the extent that they are available, HCRU \[i.e., radiation therapy, transfusions (red blood cells or platelets), inpatient admissions, treatment-related outpatient visits, emergency department visits, palliative care outpatient visits\] that occurred during BLENREP treatment will be summarized by the percentage and frequency distribution of patients with any occurrence of the respective outcome.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Healthcare Resource Utilization (HCRU)
Received Radiation Therapy
|
3 Participants
|
|
Healthcare Resource Utilization (HCRU)
Transfusions
|
7 Participants
|
|
Healthcare Resource Utilization (HCRU)
Inpatient Admissions
|
10 Participants
|
|
Healthcare Resource Utilization (HCRU)
Treatment-Related Outpatient Visits
|
20 Participants
|
|
Healthcare Resource Utilization (HCRU)
Emergency Department Visits
|
11 Participants
|
|
Healthcare Resource Utilization (HCRU)
Palliative Care Outpatient Visit
|
10 Participants
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Population: The 30 patients in the study reported specific symptoms a total of 192 times at clinic visits. The analysis population is the 192 symptoms reported.
Study procedures included recording ocular symptoms reported by patients documented in the clinic notes. These were categorized into blurry vision, dry eyes, photophobia and other symptoms (including foreign-body sensation, "grittiness", "itch/scratchiness", irritation, and tearing). This Data table reports the total number of Ocular Symptoms reported by patients, along with counts and percentage by type of symptom.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=192 Ocular Symptoms
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Number of Ocular Symptoms Reported
Other
|
32 Ocular Symptoms
|
|
Ophthalmology: Number of Ocular Symptoms Reported
Number of Ocular Symptoms reported
|
192 Ocular Symptoms
|
|
Ophthalmology: Number of Ocular Symptoms Reported
Blurry Vision
|
102 Ocular Symptoms
|
|
Ophthalmology: Number of Ocular Symptoms Reported
Dry Eyes
|
32 Ocular Symptoms
|
|
Ophthalmology: Number of Ocular Symptoms Reported
Photophobia
|
26 Ocular Symptoms
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Population: The 30 patients in the study experienced ocular toxicity (corneal events) a total of 323 times as reported during clinic visits. The analysis population is the 323 events reported.
Ocular toxicity as measured by corneal events per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. Corneal examination changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: Cornea clear/No change from baseline. Grade 1: Mild superficial keratopathy with or without symptoms. Grade 2: Moderate superficial keratopathy. Grade 3: Severe superficial keratopathy. Moderate/Severe keratopathy could be with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity. Grade 4: Corneal epithelial defect (such as corneal ulcer). The Data table reports the total number of corneal events experienced, along with counts and percentage by grade of event.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=323 Corneal Events
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Total Number of Corneal Events
|
323 Corneal Events
|
|
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Grade 1
|
158 Corneal Events
|
|
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Grade 2
|
158 Corneal Events
|
|
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Grade 3
|
4 Corneal Events
|
|
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Grade 4
|
3 Corneal Events
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Clinically Meaningful Event is defined as an event that is grade \>= 2 for which BLENREP administration is halted until the event resolves to grade \<= 1. Time to resolution is calculated for events that resolved. Unresolved events are those that had not returned to grade \<=1 at last contact due to either end of study or lost to ophthalmologic follow-up. There were 64 resolved events for Corneal Events that were analyzed
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=64 Resolved Events
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Corneal Events
|
6 Weeks
Interval 2.0 to 22.0
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Population: The 30 patients in the study experienced ocular toxicity (changes to BVCA) a total of 244 times as reported during clinic visits. The analysis population is the 244 BVCA changes reported.
Ocular toxicity as measured by changes to BVCA as measured per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. BVCA changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: No decline from baseline on Snellen Visual Acuity. Grade 1: Decline from baseline of 1 line on Snellen Visual Acuity. Grade 2: Decline from baseline of 2 or 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 3: Decline from baseline of more than 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 4: Snellen Visual Acuity worse than 20/200. The Data table reports the total number of BVCA changes experienced, along with counts and percentage by grade of change.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=244 BVCA Changes
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Total Number of Changes to BVCA
|
244 BVCA Changes
|
|
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Grade 1
|
125 BVCA Changes
|
|
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Grade 2
|
111 BVCA Changes
|
|
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Grade 3
|
8 BVCA Changes
|
|
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Grade 4
|
0 BVCA Changes
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.Clinically Meaningful Event is defined as an event that is grade \>= 2 for which BLENREP administration is halted until the event resolves to grade \<= 1. Time to resolution is calculated for events that resolved. Unresolved events are those that had not returned to grade \<=1 at last contact due to either end of study or lost to ophthalmologic follow-up. There were 44 Resolved events for changes in Best Corrected Visual Acuity that were analyzed.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=44 Resolved Events
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Best Corrected Visual Acuity
|
6 Weeks
Interval 3.0 to 53.0
|
POST_HOC outcome
Timeframe: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.The number and percentage of patients who were in Hospice Care prior to death. Analyzed for the 10 patients who died as of last follow-up Dec. 1st 2023.
Outcome measures
| Measure |
Multiple Myeloma/Blenrep Participants
n=10 Participants
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
|
|---|---|
|
Hospice Care Given Prior to Death
Yes
|
4 Participants
|
|
Hospice Care Given Prior to Death
No
|
5 Participants
|
|
Hospice Care Given Prior to Death
Unknown
|
1 Participants
|
Adverse Events
Multiple Myeloma/Blenrep Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multiple Myeloma/Blenrep Participants
n=30 participants at risk
Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023.
|
|---|---|
|
Eye disorders
Keratopathy
|
93.3%
28/30 • Number of events 320 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Corneal epithelium defect
|
10.0%
3/30 • Number of events 3 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Visual acuity reduced
|
90.0%
27/30 • Number of events 244 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Blurred vision
|
80.0%
24/30 • Number of events 102 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Dry eye
|
30.0%
9/30 • Number of events 32 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Photophobia
|
30.0%
9/30 • Number of events 26 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Foreign body sensation in the eye
|
13.3%
4/30 • Number of events 6 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Eye pruritus
|
6.7%
2/30 • Number of events 10 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Eye pain
|
10.0%
3/30 • Number of events 5 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Eye irritation
|
23.3%
7/30 • Number of events 9 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Lacrimation increased
|
3.3%
1/30 • Number of events 1 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Eye disorders
Ocular discomfort
|
3.3%
1/30 • Number of events 1 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
6/30 • Number of events 8 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
2/30 • Number of events 3 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
2/30 • Number of events 3 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
|
Investigations
Abnormal LFT (liver function test)
|
3.3%
1/30 • Number of events 2 • Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
|
Additional Information
Dr. Thomas W. LeBlanc
Duke University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place